QC LIMS Developer

Position Overview:

The QC LIMS Developer designs, configures, validates, and supports Laboratory Information Management System (LIMS) capabilities for Quality Control laboratories. This role builds compliant digital workflows for sample lifecycle, stability, specifications, CoAs, instrument/data integrations, and reporting, ensuring data integrity, GMP compliance, and on-time product/material release.

Company Overview:

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description:

What You'll Do: 

• Solution design and configuration

• • Translate QC business requirements into LIMS workflows (sample login, testing, results entry/review/approval, CoA generation, stability, EM, utilities, raw materials, in-process/finished product).

  • Configure master data: tests, methods, specifications, limits, calculations, units, instruments, users/roles, security, audit trails, electronic signatures.

  • Build dashboards, queries, and reports (KPIs, turnaround time, RFT metrics, EM trending, stability pulls) using native LIMS tools and reporting platforms.

• Integrations and automation

• • Integrate instruments and systems (CDS such as Empower; ELN; ERP like SAP/Oracle)

  • Implement results parsing and automated calculations; manage instrument metadata and result mapping.

• Compliance and validation (GxP)

• • Author and execute CSV deliverables: URS, FRS, HDS, configuration specs, risk assessments, test scripts (IQ/OQ/PQ), validation summary reports.

  • Ensure 21 CFR Part 11 / EU Annex 11 adherence, ALCOA+ data integrity, and Good Documentation Practices; maintain change control and periodic review.

  • Support audits/inspections; maintain audit-readiness for LIMS and connected systems.

• Operations and support

• • Provide application support, incident/problem management, and root-cause analysis; monitor job/integration health and performance.

  • Manage environments and releases (dev/test/qual/prod), versioning, and migrations; follow SDLC and Agile/Scrum practices.

  • Lead data migration/cleanup projects; build scripts for bulk loads and master data maintenance.

  • Create user guides/SOPs/WIs; train end users (multiple departments).

• Continuous improvement

• • Identify digital opportunities to reduce cycle time and errors; implement templates, macros, and standardized builds across sites/products.

  • Partner with QC, QA, Validation/CSV, IT Security, and Manufacturing to align solutions with contamination control strategy and right-first-time goals.

Qualifications

• Bachelor’s in Computer Science/Information Systems, Chemistry, Biochemistry, or related field; Master’s a plus.

• 3–7 years configuring and supporting LIMS in GMP environments (pharma/biotech/med device).

• • Hands-on with one or more platforms (e.g., LabWare, LabVantage, SampleManager, Nautilus, STARLIMS).

  • Proven CSV experience and familiarity with FDA 21 CFR 210/211/11, EU Annex 11, GAMP 5, ICH Q9/Q10.

  • Understanding of QC lab processes (raw materials, compendial testing, stability, EM/utilities, microbiology, chromatography workflows).

Knowledge & Capabilities: 

• Scripting/config: SQL; LabWare LIMS Basic or LabVantage Java/Groovy; .NET/Java/Python for integrations; XML/JSON.
• Databases: Oracle and/or SQL Server
• Interfaces: file-based integrations; experience with CDS (Empower/Chromeleon), ELN/LES, and label systems.
• Reporting: Crystal Reports, Jasper, Power BI/Tableau; LIMS native query/report tools.

• Strong requirements gathering, documentation, and communication.

• Analytical problem solving; ability to translate lab needs into scalable, compliant solutions.

• Stakeholder management and training aptitude; comfortable in fast-paced, regulated settings.

• Strong analytical and problem-solving skills.

Preferred Qualifications

• Knowledge of LabWare LIMS version 8 table relationships.

• Experience with Crystal reports.

• Excellent verbal and written communication skills.

Physical Requirements:

• Will work in environment which may necessitate respiratory protection
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time (240 minutes)
• Ability to sit for prolonged periods of time (240 minutes)
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers
• Ability to conduct work that includes moving objects up to 33lbs
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. 
• Will work in warm/cold environments (0-100F range)

 

Benefits

 

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth! 

 

*#LI-onsite

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

 

EEO Information:

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information:

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).